Trauma History and Depression Predict Incomplete Adherence to Antiretroviral Therapies in a Low Income Country

Background

As antiretroviral therapy (ART) for HIV becomes increasingly available in low and middle income countries (LMICs), understanding reasons for lack of adherence is critical to stemming the tide of infections and improving health. Understanding the effect of psychosocial experiences and mental health symptomatology on ART adherence can help maximize the benefit of expanded ART programs by indicating types of services, which could be offered in combination with HIV care.

Methodology

The Coping with HIV/AIDS in Tanzania (CHAT) study is a longitudinal cohort study in the Kilimanjaro Region that included randomly selected HIV-infected (HIV+) participants from two local hospital-based HIV clinics and four free-standing voluntary HIV counselling and testing sites. Baseline data were collected in 2008 and 2009; this paper used data from 36 month follow-up interviews (N = 468). Regression analyses were used to predict factors associated with incomplete self-reported adherence to ART.

Results

Incomplete ART adherence was significantly more likely to be reported amongst participants who experienced a greater number of childhood traumatic events: sexual abuse prior to puberty and the death in childhood of an immediate family member not from suicide or homicide were significantly more likely in the non-adherent group and other negative childhood events trended toward being more likely. Those with incomplete adherence had higher depressive symptom severity and post-traumatic stress disorder (PTSD). In multivariable analyses, childhood trauma, depression, and financial sacrifice remained associated with incomplete adherence.

Discussion

This is the first study to examine the effect of childhood trauma, depression and PTSD on HIV medication adherence in a low income country facing a significant burden of HIV. Allocating spending on HIV/AIDS toward integrating mental health services with HIV care is essential to the creation of systems that enhance medication adherence and maximize the potential of expanded antiretroviral access to improve health and reduce new infections.     

Reasons for Missing Antiretroviral Therapy: Results from a Multi-Country Study in Tanzania,Uganda, and Zambia

Objectives

To identify the reasons patients miss taking their antiretroviral therapy (ART) and the proportion who miss their ART because of symptoms; and to explore the association between symptoms and incomplete adherence.

Methods

Secondary analysis of data collected during a cross-sectional study that examined ART adherence among adults from 18 purposefully selected sites in Tanzania, Uganda, and Zambia. We interviewed 250 systematically selected patients per facility (≥18 years) on reasons for missing ART and symptoms they had experienced (using the HIV Symptom Index). We abstracted clinical data from the patients’ medical, pharmacy, and laboratory records. Incomplete adherence was defined as having missed ART for at least 48 consecutive hours during the past 3 months.

Results

Twenty-nine percent of participants reported at least one reason for having ever missed ART (1278/4425). The most frequent reason was simply forgetting (681/1278 or 53%), followed by ART-related hunger or not having enough food (30%), and symptoms (12%). The median number of symptoms reported by participants was 4 (IQR: 2–7). Every additional symptom increased the odds of incomplete adherence by 12% (OR: 1.1, 95% CI: 1.1–1.2). Female participants and participants initiated on a regimen containing stavudine were more likely to report greater numbers of symptoms.

Conclusions

Symptoms were a common reason for missing ART, together with simply forgetting and food insecurity. A combination of ART regimens with fewer side effects, use of mobile phone text message reminders, and integration of food supplementation and livelihood programmes into HIV programmes, have the potential to decrease missed ART and hence to improve adherence and the outcomes of ART programmes.     

Food Insecurity Is Associated with Increased Risk of Non-Adherence to Antiretroviral Therapy among HIV-Infected Adults in the Democratic Republic of Congo: A Cross-Sectional Study

Background

Food insecurity is increasingly reported as an important barrier of patient adherence to antiretroviral therapy (ART) in both resource-poor and rich settings. However, unlike in resource rich-settings, very few quantitative studies to date have investigated the association of food insecurity with patient adherence to ART in Sub-Saharan Africa. The current study examines the association between food insecurity and adherence to ART among HIV-infected adults in the Democratic Republic of Congo (DRC).

Methods and Findings

This is a cross-sectional quantitative study of patients receiving ART at three private and one public health facilities in Kinshasa, DRC. Participants were consecutively recruited into the study between April and November 2012. Adherence was measured using a combined method coupling pharmacy refill and self-reported adherence. Food insecurity was the primary predictor, and was assessed using the Household Food Insecurity Access Scale (HFIAS). Of the 898 participants recruited into the study, 512 (57%) were food insecure, and 188 (20.9%) were not adherent to ART. Food insecurity was significantly associated with non-adherence to ART (AOR, 2.06; CI, 1.38–3.09). We also found that perceived harmfulness of ART and psychological distress were associated respectively with increased (AOR, 1.95; CI, 1.15–3.32) and decreased (AOR, 0.31; CI, 0.11–0.83) odds of non-adherence to ART.

Conclusion

Food insecurity is prevalent and a significant risk factor for non-adherence to ART among HIV-infected individuals in the DRC. Our findings highlight the urgent need for strategies to improve food access among HIV-infected on ART in order to ensure patient adherence to ART and ultimately the long-term success of HIV treatment in Sub-Saharan Africa.     

Male,Mobile, and Moneyed: Loss to Follow-Up vs. Transfer of Care in an Urban African Antiretroviral Treatment Clinic

Objectives

The purpose of this study was to analyze characteristics, reasons for transferring, and reasons for discontinuing care among patients defined as lost to follow-up (LTFU) from an antiretroviral therapy (ART) clinic in Nairobi, Kenya.

Design

The study used a prospective cohort of patients who participated in a randomized, controlled ART adherence trial between 2006 and 2008.

Methods

Participants were followed from pre-ART clinic enrollment to 18 months after ART initiation, and were defined as LTFU if they failed to return to clinic 4 weeks after their last scheduled visit. Reasons for loss were captured through phone call or home visit. Characteristics of LTFU who transferred care and LTFU who did not transfer were compared to those who remained in clinic using log-binomial regression to estimate risk ratios.

Results

Of 393 enrolled participants, total attrition was 83 (21%), of whom 75 (90%) were successfully traced. Thirty-seven (49%) were alive at tracing and 22 (59%) of these reported having transferred their antiretroviral care. In the final model, transfers were more likely to have salaried employment [Risk Ratio (RR), 2.7; 95% confidence interval (CI), 1.2-6.1; p=0.020)] and pay a higher monthly rent (RR, 5.8; 95% CI, 1.3-25.0; p=0.018) compared to those retained in clinic. LTFU who did not transfer care were three times as likely to be men (RR, 3.1; 95% CI, 1.1-8.1; p=0.028) and nearly 4 times as likely to have a primary education or less (RR, 3.8; 95% CI, 1.3-10.6; p=0.013). Overall, the most common reason for LTFU was moving residence, predominantly due to job loss or change in employment.

Conclusion

A broad definition of LTFU may include those who have transferred their antiretroviral care and thereby overestimate negative effects on ART continuation. Interventions targeting men and considering mobility due to employment may improve retention in urban African ART clinics.

Clinical Trials

The study’s ClinicalTrials.gov identifier is NCT00273780.     

Effect of Couples Counselling on Reported HIV Risk Behaviour among HIV Serodiscordant Couples by ART Use,HIV Status and Gender in Rural Uganda

Background

We examined several measures of self-reported HIV risk behaviour in mutually disclosed sero-discordant couples over time to see if a couples counselling intervention was associated with changes in these behaviors.

Methods

We analysed data from a prospective cohort study of HIV sero-discordant couples in Jinja, Uganda collected between June 2009 and December 2011. Participants received couples counselling, at 3-monthly intervals. We examined trends in reported condom-use, number of concurrent sexual partners, knowledge of HIV serostatus of concurrent partners and condom use of concurrent partners using Generalized Estimating Equation models, comparing responses at study enrollment with responses at six, 12 18 and 24 months of follow-up.

Results

A total of 586 couples were enrolled and the female member was HIV positive in 255 (44%) of them. The median age for female participants was 35 years and 42 years for men. Reported condom use at last sex with spouse increased over time (p<0.001) with the largest increases found among couples where the positive participant never received ART during the study(an increase from 68.8% at enrollment to 97.1% at 24 months). Male participants reported reductions in the number of concurrent sexual partners (p<0.001), increase in the knowledge of the HIV serostatus of these partners (p = 0.001) and a trend towards improved condom-use among non-primary partners (p = 0.070). Reported reduced risky behaviors did not wane over the study period.

Conclusion

Couples counselling resulted in increased condom use among all participants and among men the intervention resulted in reductions in risk behaviour with concurrent sexual partners. Routine counselling for serodiscordant couples should be integrated in routine ART care programs.     

The Use of Pill Counts as a Facilitator of Adherence with Antiretroviral Therapy in Resource Limited Settings

Background

Pill counts are often used to measure adherence to ART, but there is little data on how they affect adherence. We previously showed a bivariate relationship between clinicians counting pills and adherence in patients receiving HIV care in Kenya. We present a secondary analysis of the relationship between numbers of pill counts and clinical outcomes in resource limited settings

Methods

Patients initiating ART at Kijabe Hospital were monitored for the number of discretionary pill counts performed by their clinician in the first 6 months of ART. Subjects were followed for at least 1 year after enrollment. The number of clinician pill counts was correlated to ART adherence. The primary endpoints were time to treatment failure, defined as a detectable HIV-1 viral load, death; or loss to follow-up.

Results

Clinician pill counts were done at 68% of clinic visits for 304 subjects. There was a positive correlation between the number of clinician pill counts and ART adherence (r = 0.21, p <0.001). Patients were divided into 3 groups (0 counts, 1 to 3 counts, 4 to 7 counts) and exhibited adherence of 76%, 84%, and 92%, respectively (p = 0.004). Time to treatment failure for these groups was 220 days, 438 days, and 497 days (P<0.01), respectively. Time to virologic failure in living patients remaining in the cohort was longer in those with more pill count (P =0.02). Multi-variate analysis adjusting for co-variates affecting time to treatment failure found that that clinician pill counts were associated with a decreased risk of treatment failure (HR = 0.69, p =0.04).

Conclusions

The number of clinician pill count performed was independently associated with better adherence and a decreased risk of treatment failure. The use of clinician pill counts should be further studied as an adherence promoter through a randomized clinical trial.     

Adherence as a Predictor of the Development of Class-Specific Resistance Mutations: The Swiss HIV Cohort Study

Background

Non-adherence is one of the strongest predictors of therapeutic failure in HIV-positive patients. Virologic failure with subsequent emergence of resistance reduces future treatment options and long-term clinical success.

Methods

Prospective observational cohort study including patients starting new class of antiretroviral therapy (ART) between 2003 and 2010. Participants were naïve to ART class and completed ≥1 adherence questionnaire prior to resistance testing. Outcomes were development of any IAS-USA, class-specific, or M184V mutations. Associations between adherence and resistance were estimated using logistic regression models stratified by ART class.

Results

Of 314 included individuals, 162 started NNRTI and 152 a PI/r regimen. Adherence was similar between groups with 85% reporting adherence ≥95%. Number of new mutations increased with increasing non-adherence. In NNRTI group, multivariable models indicated a significant linear association in odds of developing IAS-USA (odds ratio (OR) 1.66, 95% confidence interval (CI): 1.04-2.67) or class-specific (OR 1.65, 95% CI: 1.00-2.70) mutations. Levels of drug resistance were considerably lower in PI/r group and adherence was only significantly associated with M184V mutations (OR 8.38, 95% CI: 1.26-55.70). Adherence was significantly associated with HIV RNA in PI/r but not NNRTI regimens.

Conclusion

Therapies containing PI/r appear more forgiving to incomplete adherence compared with NNRTI regimens, which allow higher levels of resistance, even with adherence above 95%. However, in failing PI/r regimens good adherence may prevent accumulation of further resistance mutations and therefore help to preserve future drug options. In contrast, adherence levels have little impact on NNRTI treatments once the first mutations have emerged.     

Explaining Adherence Success in Sub-Saharan Africa: An Ethnographic Study

Background

Individuals living with HIV/AIDS in sub-Saharan Africa generally take more than 90% of prescribed doses of antiretroviral therapy (ART). This number exceeds the levels of adherence observed in North America and dispels early scale-up concerns that adherence would be inadequate in settings of extreme poverty. This paper offers an explanation and theoretical model of ART adherence success based on the results of an ethnographic study in three sub-Saharan African countries.

Methods and Findings

Determinants of ART adherence for HIV-infected persons in sub-Saharan Africa were examined with ethnographic research methods. 414 in-person interviews were carried out with 252 persons taking ART, their treatment partners, and health care professionals at HIV treatment sites in Jos, Nigeria; Dar es Salaam, Tanzania; and Mbarara, Uganda. 136 field observations of clinic activities were also conducted. Data were examined using category construction and interpretive approaches to analysis. Findings indicate that individuals taking ART routinely overcome economic obstacles to ART adherence through a number of deliberate strategies aimed at prioritizing adherence: borrowing and “begging” transport funds, making “impossible choices” to allocate resources in favor of treatment, and “doing without.” Prioritization of adherence is accomplished through resources and help made available by treatment partners, other family members and friends, and health care providers. Helpers expect adherence and make their expectations known, creating a responsibility on the part of patients to adhere. Patients adhere to promote good will on the part of helpers, thereby ensuring help will be available when future needs arise.

Conclusion

Adherence success in sub-Saharan Africa can be explained as a means of fulfilling social responsibilities and thus preserving social capital in essential relationships.     

A Stochastic Multi-Scale Model of HIV-1 Transmission for Decision-Making: Application to a MSM Population

Background

In the absence of an effective vaccine against HIV-1, the scientific community is presented with the challenge of developing alternative methods to curb its spread. Due to the complexity of the disease, however, our ability to predict the impact of various prevention and treatment strategies is limited. While ART has been widely accepted as the gold standard of modern care, its timing is debated.

Objectives

To evaluate the impact of medical interventions at the level of individuals on the spread of infection across the whole population. Specifically, we investigate the impact of ART initiation timing on HIV-1 spread in an MSM (Men who have Sex with Men) population.

Design and Methods

A stochastic multi-scale model of HIV-1 transmission that integrates within a single framework the in-host cellular dynamics and their outcomes, patient health states, and sexual contact networks. The model captures disease state and progression within individuals, and allows for simulation of therapeutic strategies.

Results

Early ART initiation may substantially affect disease spread through a population.

Conclusions

Our model provides a multi-scale, systems-based approach to evaluate the broader implications of therapeutic strategies.     

Pharmaceutical Availability across Levels of Care: Evidence from Facility Surveys in Ghana,Kenya, and Uganda

Objective

In this study we use facility-level data from nationally representative surveys conducted in Ghana, Kenya, and Uganda to understand pharmaceutical availability within the three countries.

Methods

In 2012, we conducted a survey to capture information on pharmaceuticals and other facility indicators from over 200 facilities in each country. We analyze data on the availability of pharmaceuticals and quantify its association with various facility-level indicators. We analyze both availability of essential medicines, as defined by the various essential medicine lists (EMLs) of each respective country, and availability of all surveyed pharmaceuticals deemed important for treatment of various high-burden diseases, including those on the EMLs.

Results

We find that there is heterogeneity with respect to availability across the three countries with Ghana generally having better availability than Uganda and Kenya. To analyze the relationship between facility-level factors and pharmaceutical stock-out we use a binomial regression model. We find that the factors associated with stock-out vary by country, but across all countries both presence of a laboratory at the facility and presence of a vehicle at the facility are significantly associated with reduced stock-out.

Conclusion

The results of this study highlight the poor availability of essential medicines across these three countries and suggest more needs to be done to strengthen the supply system so that stock remains uninterrupted.     

Livelihood Experiences and Adherence to HIV Antiretroviral Therapy among Participants in a Food Assistance Pilot in Bolivia: A Qualitative Study

Introduction

Health and development organizations increasingly promote livelihood interventions to improve health and economic outcomes for people living with HIV (PLHIV) receiving treatment with antiretroviral therapy (ART). In-depth understanding about how PLHIV make labor decisions in the context of treatment for HIV – and treatment decisions in the context of their livelihoods – is essential to guiding intervention design and developing hypotheses for future research on livelihoods and ART. However, few studies have explored the perspectives of PLHIV regarding integration of livelihoods and ART in urban, resource-limited settings.

Methods

Qualitative interviews explored the livelihood experiences of food insecure ART patients in four Bolivian cities (n = 211). Topics included work-related barriers to ART adherence, HIV-related barriers to work, and economic coping mechanisms. Themes were identified using content coding procedures, with two coders to maximize reliability.

Results

Participants reported complex economic lives often characterized by multiple economic activities, including both formal and informal labor. They struggled to manage ART treatment and livelihoods simultaneously, and faced a range of interpersonal and structural barriers. In particular, lack of HIV status disclosure, stigma, and discrimination were highly salient issues for study participants and likely to be unique to people with HIV, leading to conflict around requesting time off for clinic visits, resentment from co-workers about time off, and difficulties adhering to medication schedules. In addition, health system issues such as limited clinic hours or drug shortages exacerbated the struggle to balance economic activities with HIV treatment adherence.

Conclusions

Improved policy-level efforts to enforce existing anti-discrimination laws, reduce HIV-related stigma, and expand health services accessibility could mitigate many of the barriers discussed by our participants, improve adherence, and reduce the need for livelihoods interventions.     

Early Detection of Poor Adherers to Statins: Applying Individualized Surveillance to Pay for Performance

Background

Medication nonadherence costs $300 billion annually in the US. Medicare Advantage plans have a financial incentive to increase medication adherence among members because the Centers for Medicare and Medicaid Services (CMS) now awards substantive bonus payments to such plans, based in part on population adherence to chronic medications. We sought to build an individualized surveillance model that detects early which beneficiaries will fall below the CMS adherence threshold.

Methods

This was a retrospective study of over 210,000 beneficiaries initiating statins, in a database of private insurance claims, from 2008-2011. A logistic regression model was constructed to use statin adherence from initiation to day 90 to predict beneficiaries who would not meet the CMS measure of proportion of days covered 0.8 or above, from day 91 to 365. The model controlled for 15 additional characteristics. In a sensitivity analysis, we varied the number of days of adherence data used for prediction.

Results

Lower adherence in the first 90 days was the strongest predictor of one-year nonadherence, with an odds ratio of 25.0 (95% confidence interval 23.7-26.5) for poor adherence at one year. The model had an area under the receiver operating characteristic curve of 0.80. Sensitivity analysis revealed that predictions of comparable accuracy could be made only 40 days after statin initiation. When members with 30-day supplies for their first statin fill had predictions made at 40 days, and members with 90-day supplies for their first fill had predictions made at 100 days, poor adherence could be predicted with 86% positive predictive value.

Conclusions

To preserve their Medicare Star ratings, plan managers should identify or develop effective programs to improve adherence. An individualized surveillance approach can be used to target members who would most benefit, recognizing the tradeoff between improved model performance over time and the advantage of earlier detection.     

Estimating PMTCT's Impact on Heterosexual HIV Transmission: A Mathematical Modeling Analysis

Introduction

Prevention of mother-to-child HIV transmission (PMTCT) strategies include combined short-course antiretrovirals during pregnancy (Option A), triple-drug antiretroviral treament (ART) during pregnancy and breastfeeding (Option B), or lifelong ART (Option B+). The WHO also recommends ART for HIV treatment and prevention of sexual transmission of HIV. The impact of PMTCT strategies on prevention of sexual HIV transmission of HIV is not known. We estimated the population-level impact of PMTCT interventions on heterosexual HIV transmission in southwestern Uganda and KwaZulu-Natal, South Africa, two regions with different HIV prevalence and fertility rates.

Materials and Methods

We constructed and validated dynamic, stochastic, network-based HIV transmission models for each region. PMTCT Options A, B, and B+ were simulated over ten years under three scenarios: 1) current ART and PMTCT coverage, 2) current ART and high PMTCT coverage, and 3) high ART and PMTCT coverage. We compared adult HIV incidence after ten years of each intervention to Option A (and current ART) at current coverage.

Results

At current coverage, Options B and B+ reduced heterosexual HIV incidence by about 5% and 15%, respectively, in both countries. With current ART and high PMTCT coverage, Option B+ reduced HIV incidence by 35% in Uganda and 19% in South Africa, while Option B had smaller, but meaningful, reductions. The greatest reductions in HIV incidence were achieved with high ART and PMTCT coverage. In this scenario, all PMTCT strategies yielded similar results.

Discussion

Implementation of Options B/B+ reduces adult HIV incidence, with greater effect (relative to Option A at current levels) in Uganda than South Africa. These results are likely driven by Uganda’s higher fertility rates.     

Trends and Determinants of Antiretroviral Therapy Patient Monitoring Practices in Kenya and Uganda

Introduction

Patients receiving antiretroviral therapy (ART) require routine monitoring to track response to treatment and assess for treatment failure. This study aims to identify gaps in monitoring practices in Kenya and Uganda.

Methods

We conducted a systematic retrospective chart review of adults who initiated ART between 2007 and 2012. We assessed the availability of baseline measurements (CD4 count, weight, and WHO stage) and ongoing CD4 and weight monitoring according to national guidelines in place at the time. Mixed-effects logistic regression models were used to analyze facility and patient factors associated with meeting monitoring guidelines.

Results

From 2007 to 2012, at least 88% of patients per year in Uganda had a recorded weight at initiation, while in Kenya there was a notable increase from 69% to 90%. Patients with a documented baseline CD4 count increased from 69% to about 80% in both countries. In 2012, 83% and 86% of established patients received the recommended quarterly weight monitoring in Kenya and Uganda, respectively, while semiannual CD4 monitoring was less common (49% in Kenya and 38% in Uganda). Initiating at a more advanced WHO stage was associated with a lower odds of baseline CD4 testing. On-site CD4 analysis capacity was associated with increased odds of CD4 testing at baseline and in the future.

Discussion

Substantial gaps were noted in ongoing CD4 monitoring of patients on ART. Although guidelines have since changed, limited laboratory capacity is likely to remain a significant issue in monitoring patients on ART, with important implications for ensuring quality care.     

The Effect of a Maturing Antiretroviral Program on Early Mortality for Patients with Advanced Immune-Suppression in Soweto,South Africa

Objective

We hypothesize that time to initiate care and maturity of a treatment program impact on outcome of severely immuno-compromised patients with higher risk of mortality.

Design

We conducted a retrospective cohort analysis at the Perinatal HIV Research Unit Adult ART clinic, Soweto, South Africa.

Methods

Eligibility criteria for this analysis were: attendance for minimum one visit between August 2004 and August 2010, age >18 years, CD4 count < 50 cells/mm³ and ART-naïve at screening. We followed participants up to one year after ART initiation. We defined years 2004-2007 and 2008-2010 as the early and late eras respectively. Chi-square test and survival analysis methods were used for mortality comparisons between eras.

Results

Of 2357 patients eligible for antiretroviral treatment, 395 (17%) had CD4 counts < 50 cells/mm³ and ART-naïve at screening. Overall 261 (66%) were women. Patients had similar median age (35 vs. 33.5 years, p=0.08), time to HAART initiation (7 days, p=0.18) and baseline CD4 count (20 vs. 23 cells/mm³, p=0.5) between eras. Overall 63 (16%) patients died in their first year of treatment (2 per 100 person-months) and the main cause of death was tuberculosis (n=23, 37%). The proportion of deaths (52/262 vs. 11/133, p=0.003) and time to death from enrolment (logrank p=0.04) were significantly different between eras.

Conclusion

Mortality decreased as the ART program matured in Soweto while time to initiation of treatment remained similar in both eras. Because ART guidelines were consistent during both eras, it is possible that with time, management of patients improved as expertise was gained.     

Duration of HIV-1 Viral Suppression on Cessation of Antiretroviral Therapy in Primary Infection Correlates with Time on Therapy

Objective

A minority of HIV-1 positive individuals treated with antiretroviral therapy (ART) in primary HIV-1 infection (PHI) maintain viral suppression on stopping. Whether this is related to ART duration has not been explored.

Design

And Methods: Using SPARTAC trial data from individuals recruited within 6 months of seroconversion, we present an observational analysis investigating whether duration of ART was associated with post-treatment viraemic control. Kaplan-Meier estimates, logistic regression and Cox models were used.

Results

165 participants reached plasma viral loads (VL) <400 copies/ml at the time of stopping therapy (ART stop). After ART stop, 159 experienced confirmed VL ≥400 copies/ml during median (IQR) follow-up of 167 (108,199) weeks.Most participants experienced VL rebound within 12 weeks from ART stop, however, there was a suggestion of a higher probability of remaining <400 copies/ml for those on ART >12 weeks compared to ≤12 weeks (p=0.061). Cumulative probabilities of remaining <400 copies/ml at 12, 52 and 104 weeks after ART stop were 21% (95%CI=13,30), 4% (1,9), and 4% (1,9) for ≤12 weeks ART, and 32% (22,42), 14% (7,22), and 5% (2,11) for >12 weeks.In multivariable regression, ART for >12 weeks was independently associated with a lower probability of being ≥400 copies/ml within 12 weeks of ART stop (OR=0.11 (95%CI=0.03,0.34), p<0.001)). In Cox models of time to VL ≥400 after 12 weeks, we only found an association with female sex (OR=0.2, p=0.001).

Conclusion

Longer ART duration in PHI was associated with a higher probability of viral control after ART stop.

Trial Registration

Controlled-Trials.com 76742797 http://www.controlled-trials.com/ISRCTN76742797.     

Post-ART Symptoms Were Not the Problem: A Qualitative Study on Adherence to ART in HIV-Infected Patients in a Mozambican Rural Hospital

Objective

The objective of this qualitative study was to explore how clinical symptoms may affect adherence to antiretroviral therapy (ART) in HIV patients, and to explore factors, perceptions and attitudes related to adherence to therapy.

Design

A qualitative study was carried out in the context of the prospective cohort study “Evaluation of Immune Reconstitution Following Initiation of Highly Active Antiretroviral Treatment in Manhiça, Mozambique”. In-depth Interviews were conducted twice in a sub-sample of the study cohort (51 participants), at six-month intervals.

Results

Most participants (73%) knew that AIDS is a chronic disease and that ART does not cure it. Nine participants (18%) were non-adherent at some point and two (4%) abandoned ART. All participants but five reported having symptoms after starting ART, mainly attributed to pills needing time to act and body’s reaction to the treatment. In spite of the perceived severity of the symptoms, only two people reported they discontinued the treatment due to symptoms. Almost all participants reported feeling comfortable with the HIV clinic organization and procedures, but afraid of staff being hostile if they did not follow the rules or if the health worker visited their home. Family was one of the most important source of support according participants. Almost all participants with children said that a decisive factor to follow the treatment was the desire to be able to look after them.

Conclusions

Experiencing symptoms after starting treatment was not a barrier to adherence to ART. Factors related to adherence included control measures set up by the health facility (exhaustive follow up, support, information) and family and community support. Indirect ART-related expenses did jeopardise adherence.     

Clinical Utility of Antithrombotic Prophylaxis in ART Procedures: An Italian Experience

Background

The usefulness of antithrombotic prophylaxis in management of Assisted Reproductive Technologies (ART) is questionable.

Objectives

We prospectively examined the contribution of an antithrombotic prophylaxis in influencing clinical pregnancy and live-birth in an unselected cohort of women approaching ART.

Patients/Methods

1107 women with fertility problems and a valid indication for ART were recruited. Baseline and follow-up information of obstetric outcomes and antithrombotic treatment were collected.

Results and Conclusions

Median follow-up time was 34.5 months (range: 2–143). During the follow-up period, 595 (53.8%) women underwent ART (total 1234 cycles); 202 (33.9%) women achieved a pregnancy for a total of 255 clinical pregnancies. The concomitant use of LMWH and aspirin was significantly associated with a higher rate of clinical pregnancies (p: 0.003, OR: 4.9, 95% CI: 1.7–14.2). The pregnancy rate was also significantly increased by the use of LMWH alone (p: 0.005, OR: 2.6, 95% CI: 1.3–5.0). Carriership of inherited or acquired thrombophilia did not affect clinical outcomes of the ART. The efficacy of antithrombotic treatment was confirmed when the outcome “ live-birth” was considered. Present data suggest a potential benefit of antithrombotic prophylaxis during ART in improving the number of live-births.     

Development of an Electronic Medical Record Based Alert for Risk of HIV Treatment Failure in a Low-Resource Setting

Background

The adoption of electronic medical record systems in resource-limited settings can help clinicians monitor patients'' adherence to HIV antiretroviral therapy (ART) and identify patients at risk of future ART failure, allowing resources to be targeted to those most at risk.

Methods

Among adult patients enrolled on ART from 2005–2013 at two large, public-sector hospitals in Haiti, ART failure was assessed after 6–12 months on treatment, based on the World Health Organization''s immunologic and clinical criteria. We identified models for predicting ART failure based on ART adherence measures and other patient characteristics. We assessed performance of candidate models using area under the receiver operating curve, and validated results using a randomly-split data sample. The selected prediction model was used to generate a risk score, and its ability to differentiate ART failure risk over a 42-month follow-up period was tested using stratified Kaplan Meier survival curves.

Results

Among 923 patients with CD4 results available during the period 6–12 months after ART initiation, 196 (21.2%) met ART failure criteria. The pharmacy-based proportion of days covered (PDC) measure performed best among five possible ART adherence measures at predicting ART failure. Average PDC during the first 6 months on ART was 79.0% among cases of ART failure and 88.6% among cases of non-failure (p<0.01). When additional information including sex, baseline CD4, and duration of enrollment in HIV care prior to ART initiation were added to PDC, the risk score differentiated between those who did and did not meet failure criteria over 42 months following ART initiation.

Conclusions

Pharmacy data are most useful for new ART adherence alerts within iSanté. Such alerts offer potential to help clinicians identify patients at high risk of ART failure so that they can be targeted with adherence support interventions, before ART failure occurs.